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510(k) Data Aggregation
(123 days)
Mission Creatinine Reagent Kit is for the quantitative determination of creatinine in serum, plasma, or urine on the Beckman Synchron CX® & CX® Delta Systems. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in renal dialysis, and as a calculation basis for measuring other urine analytes.
Creatinine is determined by mixing a sample with the alkaline picric reagent, Creatinine from the sample combines with the reagent to produce a red-colored complex. Absorbance readings are taken at both 520 nm and 560 nm at 25.6 seconds after sample addition. The differential absorbance is a direct measure of the concentration of Creatinine in the sample.
Here's a breakdown of the acceptance criteria and study information based on the provided text, structured to address your specific questions:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to the predicate device and the specified guidelines (NCCLS EP5-A and EP9-A2). The "acceptance" is demonstrated by the Mission Creatinine Reagent exhibiting "similar" performance characteristics to the Beckman Creatinine Reagent.
| Performance Metric | Acceptance Criteria (Implied/Compared) | Reported Device Performance (Mission Reagent) |
|---|---|---|
| Precision | Meeting NCCLS Guideline EP5-A standards (typical ranges for clinical assays) and showing comparable precision to the predicate device. | Serum Control 1 (1.6 mg/dL): Swr (within run sd) = 0.07 mg/dL (4.4% CV) ST (Total sd) = 0.14 mg/dL (8.4% CV) Serum Control 2 (6.9 mg/dL): Swr (within run sd) = 0.10 mg/dL (1.5% CV) ST (Total sd) = 0.62 mg/dL (8.9% CV) Urine Control 1 (89 mg/dL): Swr (within run sd) = 0.7 mg/dL (0.8% CV) ST (Total sd) = 10.9 mg/dL (12.3% CV) Urine Control 2 (217 mg/dL): Swr (within run sd) = 2.2 mg/dL (1.0% CV) ST (Total sd) = 9.5 mg/dL (4.4% CV) |
| Method Comparison (Serum) | Good correlation with the predicate device (Beckman Reagent) as per NCCLS Guideline EP9-A2, with a strong linear relationship (r² close to 1) and small systematic/proportional bias. | Mission = 1.000 x Beckman + 0.003 Range = 0.2 to 11.8 mg/dL r² = 0.998 df = 70 n = 71 S(yx) = 0.13 mg/dL |
| Method Comparison (Urine) | Good correlation with the predicate device (Beckman Reagent) as per NCCLS Guideline EP9-A2, with a strong linear relationship (r² close to 1) and small systematic/proportional bias. | Mission = 0.988 x Beckman + 0.634 Range = 10 to 400 mg/dL r² = 0.999 df = 44 n = 45 S(yx) = 3.17 mg/dL |
| Recovery to Expected Values (Serum) | Similar recovery to the predicate device, ideally within a clinically acceptable range (e.g., 90-110%). | Range of average % Recovery: 85.7 - 105.3 Overall Mean Recovery: 98.5 Comparable to Beckman's 93.4 - 114.3 range and 104.2 mean |
| Recovery to Expected Values (Urine) | Similar recovery to the predicate device, ideally within a clinically acceptable range. | Range of average % Recovery: 87 - 102.1 Overall Mean Recovery: 96 Comparable to Beckman's 83 - 102.9 range and 96.2 mean |
| Functional Sensitivity | Lowest level where %CV is less than 20% should be adequate for clinical use and comparable to the predicate. | Lowest level with %CV < 20% observed at expected 0.9 mg/dL Creatinine (which measured 0.57 mg/dL with Mission, 0.79 mg/dL with Beckman). At 0.57 mg/dL, Mission's %CV was 12.9%. (Beckman at 0.79 mg/dL had 7.0 %CV). This suggests the functional sensitivity for Mission is around 0.6 mg/dL, which is comparable to the predicate's 0.8 mg/dL, for the criterion of %CV < 20%. |
Study Details
2. Sample size(s) used for the test set and the data provenance
- Precision:
- Sample Size: 80 for each control (Serum Control 1, Serum Control 2, Urine Control 1, Urine Control 2). Total of 320 observations.
- Data Provenance: Not explicitly stated, but clinical laboratory controls are typically pooled human or synthetic samples. The study was conducted following NCCLS Guideline EP5-A. Likely prospective, as samples were run over 20 days.
- Method Comparison:
- Serum: n = 71 samples (serum samples were spiked or diluted).
- Urine: n = 45 samples (urine controls were spiked or diluted).
- Data Provenance: Not explicitly stated, but the comparison involves running samples with both the Mission and Beckman reagents simultaneously. Likely prospective, generated for this study.
- Recovery to Expected Values:
- Serum: Varying dilutions from a high of 9.04 mg/dL to a low of 0.20 mg/dL. The number of samples/dilutions isn't a single 'n' but represents a range of tested concentrations.
- Urine: Varying dilutions from 400 mg/dL to 10 mg/dL.
- Data Provenance: Not explicitly stated, but involved spiking and diluting pooled serum and urine controls. Likely prospective, generated for this study.
- Functional Sensitivity:
- Sample Size: Each dilution was tested as 4 samples per run over 5 calibrated runs. For the 0.90 mg/dL expected value, N=20; for 0.30 mg/dL, N=20; for 0.18 mg/dL, N=20; for 0.04 mg/dL, N=5 (Mission) and N=2 (Beckman); for 0.00 mg/dL, N=9 (Mission) and N=11 (Beckman).
- Data Provenance: Dilutions of serum samples and a zero. Likely prospective, generated for this study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the device is an in-vitro diagnostic (IVD) reagent for quantitative chemical analysis. Ground truth is established by the known concentration of controls/spiked samples or by comparison to a legally marketed predicate device, not by expert interpretation.
4. Adjudication method for the test set
This information is not applicable for this type of IVD device. Adjudication is relevant for scenarios involving human interpretation, often clinical or imaging diagnosis, where discrepancies between readers or between reader and ground truth need to be resolved. For quantitative chemical measurements, the output is a numerical value which is then compared against known values or a predicate.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. This is an IVD reagent, not an AI-assisted diagnostic tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is an IVD reagent, so the "device" (reagent) operates standalone in conjunction with the analytical instrument (Beckman Synchron CX & CX Delta Systems). The performance data presented (precision, correlation, recovery, functional sensitivity) inherently represents the standalone performance of the reagent on the specified instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device's performance evaluation was established using:
- Known concentrations: For control materials (serum/urine controls) used in precision studies.
- Expected values: For spiked or diluted samples in method comparison and recovery studies. Creatinine was added gravimetrically for some recovery samples.
- Predicate Device: The Beckman Creatinine Reagent served as the reference standard against which the Mission Reagent's performance was compared for correlation, recovery, and functional sensitivity. The premise is that the predicate device is already recognized as providing accurate measurements.
8. The sample size for the training set
This information is not applicable. This is a chemical reagent, not a machine learning model, so there is no "training set" in the computational sense. The "development" of the reagent would involve chemical formulation and optimization, not data-driven machine learning training.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as point 8.
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(54 days)
The creatinine reagents: Alkaline Diluent(R1), product No. CA105-01 and Piccio Acid ed the second of a CA105-02-are intended for Invitro Diagnostic use in the automated, The creatinine reagents: Alkaline Diluent(R1), product No. CH10507 use in the automated, (R2), product No. CA105-02 are intended for Invitro Diagnosic use in the automated, (R2), product No. CA105-02 are intended for Interest of the
CREATININE Reagent
The provided document is a 510(k) clearance letter for a medical device called "CREATININE Reagent". It outlines the FDA's decision to clear the device for marketing based on substantial equivalence to a predicate device. However, the document does not contain any information regarding the acceptance criteria, study details, performance data, or ground truth establishment for the CREATININE Reagent device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The document is a regulatory approval letter, not a scientific study report.
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(82 days)
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